Description

Sitagliptin Impurity 28 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Sitagliptin. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is an essential material for research and development, method validation, and routine batch testing within the pharmaceutical industry.

Application

• Pharmaceutical Impurity Profiling: Primary use as a certified reference standard for the identification and quantification of Sitagliptin Impurity 28 in Sitagliptin API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate stability-indicating chromatographic methods for impurity analysis.
• Quality Control & Batch Release Testing: Serves as a system suitability standard and quantitative calibrant in routine QC laboratories to ensure API batches meet stringent pharmacopeial (e.g., USP, EP) specifications.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Contract Research Organizations (CROs): Used by CROs providing analytical testing services to pharmaceutical clients.

Basic Information

Product Name	Sitagliptin Impurity 28
CAS No.	898543-70-9
Molecular Formula	C16H15F6N5O
Molecular Weight	407.31 g/mol
Synonyms	7-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3-a]pyrazine; (R)-7-(3-Amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine; Sitagliptin Related Compound 28; Januvia Impurity 28; MK-0431 Impurity 28; DPP-4 Inhibitor Impurity.
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Impurity 28 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.